Sanofi-Aventis launches major insulin research program; updates on rimonabant court case

French drug major Sanofi-Aventis has announced an action plan to provide methodologically robust research that will contribute to the scientific resolution of the debate over insulin safety, including insulin analogs and Lantus (insulin glargine),and has given an update on a US law suit concerning rimonabant.

The research program is designed to generate more information on whether there is any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine and other insulins. This matter has been the subject of extensive discussion and debate within the scientific and medical communities for many years. While there is a consensus among leading scientists around the world regarding the difficulties of developing conclusive evidence, Sanofi-Aventis says it is committed to exploring this matter in depth, as was communicated by the company earlier this year.

The drugmaker's scientific plan will encompass state-of-the-art preclinical and clinical programs involving human insulin and insulin glargine. Preclinical studies will assess the differential effects of insulin glargine, its metabolites and other insulins in various models. The clinical development plan is based on several rigorous epidemiological studies, designed and implemented with the support of international experts and institutions, that will be conducted across Europe and North America. The plan is structured to yield short-term and longer-term results.